Your session is about to expire
← Back to Search
Procedure
Multimodal Therapy for Brain AVM (TOBAS Trial)
N/A
Recruiting
Led By Daniel Roy, MD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Any patient with a brain AVM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years post-treatment (or randomization)
Awards & highlights
TOBAS Trial Summary
This trial is designed to improve long-term outcomes for patients with brain arteriovenous malformations by testing different therapies.
Who is the study for?
The TOBAS study is for patients with brain arteriovenous malformations (AVMs), which are tangles of abnormal blood vessels connecting arteries and veins in the brain. It's open to all such patients, except those needing urgent surgery due to bleeding effects from AVM.Check my eligibility
What is being tested?
This trial explores whether medical management or interventional therapies like embolization, neurosurgery, or radiation—alone or combined—can significantly reduce death/stroke risks in AVM patients over a decade. It also examines if pre-treatment embolization can enhance the success of other treatments.See study design
What are the potential side effects?
Potential side effects include complications from endovascular procedures, surgical risks associated with neurosurgery, and typical reactions to radiation therapy. The goal is an acceptable risk level of permanent disabling neurological issues at 8%.
TOBAS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a brain AVM.
TOBAS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years post-treatment (or randomization)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years post-treatment (or randomization)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
composite event of death from any cause or disabling stroke
Secondary outcome measures
Permanent disabling peri-operative complications
occurrence of any neurological event
TOBAS Trial Design
2Treatment groups
Active Control
Group I: Interventional therapyActive Control3 Interventions
Interventional therapies include:
neurosurgery (surgical resection when the lesion is considered by a multidisciplinary team to be safely 'operable'); radiation therapy (when the AVM is smaller than 3 cm, and considered to not be safely 'operable'); radiosurgery, alone or in combination, with or without endovascular procedure; curative embolization (when the lesion is considered curable by embolization).
Patients with AVMs that the multidisciplinary team judges could potentially benefit from endovascular treatment prior to surgical resection or radiation therapy will then also be pre-randomly allocated to embolization or to no embolization.
Group II: Conservative management (medical management)Active Control1 Intervention
The conservative, or medical management arm, involves pharmacological therapy as deemed appropriate for medical symptoms as determined by the treating investigator. Should patients in the conservative management arm develop hemorrhage or infarction related to their AVM, they then potentially become candidates for interventional therapy.
Find a Location
Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
128,637 Total Patients Enrolled
Centre Hospitalier Régional et Universitaire de BrestOTHER
8 Previous Clinical Trials
20,073 Total Patients Enrolled
Daniel Roy, MDPrincipal InvestigatorCHUM-Montreal
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a brain AVM.I had surgery for a bleeding in my brain that needed immediate attention.
Research Study Groups:
This trial has the following groups:- Group 1: Interventional therapy
- Group 2: Conservative management (medical management)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the scope of participants in this medical experiment?
"Affirmative. The trial's information on clinicaltrials.gov shows that it is still actively recruiting volunteers, which began May 1st 2014 and was most recently edited June 9th 2022. This study requires 1000 participants from 5 distinct medical centres to be enrolled in the experiment."
Answered by AI
Are there still opportunities to participate in the study?
"Affirmative. Clinicaltrial.gov clearly indicates that this research study, which was initially published on May 1st 2014, is actively seeking participants. At present, there are 1000 patients needed from 5 separate medical facilities."
Answered by AI
Are there numerous establishments in North America providing this clinical investigation?
"This clinical trial is presently seeking participants from 5 medical sites located in Boston, Montreal, Edmonton and additional locations. To minimize the burden of travel, it would be ideal to select a clinic close by if you decide to join this study."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger